A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease

Part of paid clinical trials in Los Angeles, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05923073
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Guselkumab — DRUG
    Guselkumab will be administered subcutaneously.
  • Guselkumab — DRUG
    Guselkumab will be administered intravenously.

Study Details

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

Key Dates

Start date
Mar 13, 2024
Status verified
Jun 2026
Primary completion
Oct 27, 2027
Completion
Jul 12, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label induction phase: Guselkumab Intravenously (IV)
    Participants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
  • Experimental: Open-label induction phase: Guselkumab Subcutaneously (SC)
    Participants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
  • Experimental: Double-blind maintenance phase: Guselkumab SC Dose Regimen 1
    At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
  • Experimental: Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2
    At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
  • Experimental: Open-label maintenance phase: Guselkumab SC
    Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.

Primary Outcome Measure

Percentage of Participants with Clinical Remission at Week 52 [ Time Frame: Week 52 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Connecticut Children's Medical CenterHartfordConnecticut06106-
Children's Center for Digestive Health CareAtlantaGeorgia30342-
Emory UniversityAtlantaGeorgia30322-
Riley Hospital for ChildrenIndianapolisIndiana46202-5225-
Boston Childrens HospitalBostonMassachusetts02115-
Goryeb Children's HospitalMorristownNew Jersey07960-
Columbia University Medical CenterNew YorkNew York10032-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis CenterNew YorkNew York10021-5663-
The Children's Medical Center of DaytonDaytonOhio45404-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Cook Childrens Medical CenterFort WorthTexas76104-
University of Vermont Medical CenterColchesterVermont05446-

Find similar trials in Los Angeles, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Cedars Sinai Medical Center· Los Angeles, CAConnecticut Children's Medical Center· Hartford, CTChildren's Center for Digestive Health Care· Atlanta, GAEmory University· Atlanta, GARiley Hospital for Children· Indianapolis, INBoston Childrens Hospital· Boston, MA

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